Gastric band

ABSTRACT

A gastric band of a belt type is presented for attaching around a circumference of a patient&#39;s stomach, so as to define the diameter of the stomach opening. The band comprises outer and inner surfaces, wherein the inner surface engages the stomach, and at least the outer surface is formed by an elongated member substantially non-extendable along a longitudinal axis thereof. A through-going opening is made in the elongated member and is located so as to define an end portion of the band having a predetermined length. An opposite end portion of the band is shaped so as to be insertable into the through-going opening for adjusting a desired inner diameter of the band in its closed operating position and fastening the opposite end portion to the outer surface of the band.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/457,233 filed on Jun. 4, 2009, which is a continuation of U.S. patentapplication Ser. No. 10/755,408 filed on Jan. 13, 2004, which is acontinuation of U.S. patent application Ser. No. 09/526,757 filed onMar. 16, 2000, now U.S. Pat. No. 6,676,674, which claims the benefit ofpriority of Israel Patent Application No. 129032 filed on Mar. 17, 1999.The contents of the above applications are incorporated by reference asif fully set forth herein.

FIELD OF THE INVENTION

This invention relates to a gastric banding device that encircles aportion of the stomach to form a stoma opening of reduced diameter.

BACKGROUND OF THE INVENTION

Morbid obesity is associated with medical risks in terms of thedevelopment of additional diseases such as diabetes, hypertension,cardiac insufficiency and other socio-psychological problems, overallreducing life expectancy. Dietary management, psychiatric or dietaryregiments are the first choice for treating morbid obesity, but as theydepend on the goodwill of the patient, especially in the long run, theseapproaches often fail.

Various surgical approaches have been developed and used for treatingmorbid obesity. These include gastric bypasses, small bowel bypasses andstapling of portions of the stomach. The stapling techniques includehorizontal and vertical stapling for reducing the volume of the stomach,as well as narrowing the stoma opening thus controlling the food intakeof the stomach. However the latter approach, stapling, may not bring thedesired results due to the fact that the staples frequently open or tendto cause perforations. Furthermore the stomach opening formed by stapleswidens over time, thus the effect is reduced or even eliminated.

A different approach to the problem specified above is described in U.S.Pat. No. 4,416,267, which discloses a method for treating obesity byplacing an inflatable balloon into the stomach. Such a device displacesvolume inside the stomach, thereby reducing the effective free volume ofthe gastric portion causing the individual to feel no need foradditional food intake. The balloon is inflated in the stomach to apredetermined volume and is left there for a certain period of timeafter which it is easily removed. However, this procedure although beingphysically easy to implement and basically being non-surgical, may leadto harmful results. The inflated balloon in the stomach is in constantcontact with gastric mucous, and such contact for an extended period oftime may give rise to gastric ulcers and intestinal blockage.

Recently, another approach has been developed based on placing aphysical means (i.e. a gastric band) outside the stomach. A gastric bandis placed around the upper part of the stomach, thereby creating analtered stomach opening of a reduced diameter, resulting in therestriction of food intake into the digestive portion of the stomach.Such a gastric-banding technique is simple as compared to theabove-mentioned balloon-based technique. However, this band has no meansfor adjusting its diameter to obtain the optimal diameter of the stomachopening.

Adjustable gastric bands have been developed, and disclosed for examplein U.S. Pat. No. 4,592,339, as well as in “A Gastric Band withAdjustable Inner Diameter for Obesity Surgery”, P. Forsell et al., ObesSurg., 1993, No. 3, pp. 303-306. According to this technique, thediameter of a belt-like band, when in a closed position thereof, may beadjusted. For this purpose, the band includes an inflatable portion inits interior part. Controllable inflating and deflating of this portionalters the stomach opening. Although this gastric band can retain thepredetermined diameter of the stomach opening, obtaining of the properopening is somewhat problematic.

U.S. Pat. No. 4,696,288 discloses a calibrating apparatus for usingwith, a gastric band for controlling the diameter of the stomach openingby regulating the band's diameter. Such a gastric band is typicallymounted with a laproscopic technique, disclosed for example in U.S. Pat.No. 5,226,429.

SUMMARY OF THE INVENTION

It is a main object of the present invention to provide a gastric bandof a belt type, which can be attached to a patient's stomach in a safemanner and without damaging the stomach circumference.

It is a further object of the present invention to provide such a bandwhich can be easily mounted on the stomach utilizing a laproscopictechnique.

It is a still further object of the present invention to provide such aband that is easily enables its facile detectable by any suitableimaging means, thereby facilitating access to the band when additionalsurgical/laproscopic intervention is desired.

There is thus provided according to one aspect of the present invention,a gastric band for attaching around a circumference of a patient'sstomach so as to define the diameter of the stomach opening, the bandcomprising:

-   -   (a) outer and inner surfaces, wherein the inner surface engages        the stomach, and at least the outer surface is formed by an        elongated member substantially non-extendable along a        longitudinal axis thereof;    -   (b) a through-going opening made in said member and located so        as to define an end portion of the band having a predetermined        length; and    -   (c) an opposite end portion of the band shaped so as to be        insertable into said through-going opening for adjusting a        desired inner diameter of the band in its closed operating        position and fastening the opposite end portion to the outer        surface of the band.

The gastric band is of a belt type, and also comprises a suitablefastening means, which may utilize a required number of stitches or theprovision of bolt-and-nut arrangements on the band. The fastening meansmay also be in the form of teeth-like edges of the opposite end portionand a correspondingly shaped through-going opening.

The outer and inner surface may be formed either of the same material,or of different materials, provided that the material of the outersurface is substantially not-extendable.

Preferably, at least the outer surface of the band is made ofpoly-tetra-fluoro-ethylene, known as Gortex. The material of the innersurface of the band engaging the stomach may be silicone. The band, whenin the operation position thereof is such that its inner surfaceengaging the stomach has a substantially circular shape.

The predetermined length of the end portion is such as to enable thedetection of the gastric band by a laproscopic inspection tool.

According to another aspect of the present invention, there is provideda system for laproscipically attaching a gastric band around a patient'sstomach so as to define a certain diameter of the stomach opening, thesystem comprising a calibration device which is insertable into thestomach at a predetermined depth and comprises:

-   -   an upper portion having variable volume, anda lower        projection-like portion having a diameter substantially equal to        said certain diameter of the stomach opening to be defined by        the band, the location of said projection-like portion when in        the inserted position of the calibration device defining the        location of the band with respect to the stomach;        said band comprising:        outer and inner surfaces, wherein the inner surface engages the        stomach, and at least the outer surface is formed by an        elongated member substantially non-extendable along a        longitudinal axis thereof;        a through-going opening made in said member and located so as to        define an end portion of the band having a predetermined length;        and        an opposite end portion of the band shaped so as to be        insertable into said through-going opening for adjusting a        desired inner diameter of the band in its closed operating        position and fastening the opposite end portion to the outer        surface of the band.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carriedout in practice, a preferred embodiment will now be described, by way ofnon-limiting example only, with reference to the accompanying drawings,in which:

FIGS. 1 a and 1 b are schematic illustrations of a gastric band in itsopen and closed positions, respectively, constructed according to oneembodiment of the invention;

FIG. 2 schematically illustrates the band of FIGS. 1 a and 1 b in itsoperation position being attached to the patient's stomach;

FIGS. 3 a and 3 b are schematic illustrations of a gastric band in itsopen and closed positions, respectively, constructed according toanother embodiment of the invention;

FIGS. 4 a and 4 b are schematic illustrations of a gastric band in itsopen and closed positions, respectively, constructed according to yetanother embodiment of the invention;

FIGS. 5 a and 5 b are schematic illustrations of a gastric band in itsopen and closed positions, respectively, constructed according to yetanother embodiment of the invention;

FIGS. 6 a and 6 b schematically illustrate two steps of a calibrationprocedure carried out prior to mounting the band on the stomach; and

FIGS. 7 a to 7 f illustrates five sequential steps, respectively, ofmounting the band of FIGS. 3 a-3 b onto the patient's stomach.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

Referring to FIGS. 1 a and 1 b there is illustrated a gastric band,generally designated 1, constructed according to one embodiment of theinvention. The band is typically an elongated strap having two oppositeend portions 1 a and 1 b. The portion 1 b is substantially cone shaped,while the end portion 1 a is formed with a through-going, substantiallyelliptically-shaped opening 4 displaced from the corresponding butt-endof the band 1 by a certain length L.sub.0, the purpose of which will bedescribed further below. For example, the band's dimensions may be asfollows:

-   -   1) the length L.sub.1 of the entire band is about 15 cm;    -   2) the length L.sub.0 is about 3 cm;    -   3) the width h.sub.0 of the band is 2 cm;    -   4) the thickness h.sub.1 of the band is 2 mm; and    -   5) the long axis L.sub.2 of the opening 4 is about 1-7 mm.

As clearly seen in FIG. 1 b, the band 1 has outer and inner surfaces 2 aand 2 b, respectively. To attach the band 1 around a stomach (not shownhere), the cone shaped end portion 1 b passes through the opening 4, andis fastened along a corresponding location on the band by a suitablefastening means, for example by stitches 6. Thereafter, the free part ofthe end portion 1 b is cut off by any suitable means, as shown in adashed line. The opposite end portion 1 a, whilst being optionallypartly stitched to the band 1, extends away therefrom. The band 1 ismade of a polymer material, which is substantially non-extendable alongits longitudinal axis. For example, poly-tetra-fluoro-ethylene (i.e.Gortex) can be used for manufacturing the band 1.

Turning now to FIG. 2, there is illustrated that, when in the operativeposition of the band 1 being attached around a stomach 10, the free endportion 1 a protrudes from the band. It will be readily understood thatsuch a protrusion would be easily detected by any suitable imagingmeans. This is a very important feature facilitating the access to theband when additional surgical/laproscopic intervention is desired

As further seen in FIG. 2, the band 1 actually defines two portions 10 aand 10 b of the stomach 10, and defines the diameter of a so-calledstomach opening (not seen here) underneath the band 1. The portions 10 aand 10 b are fastened to each other by stitches 12 or the like withinthe vicinity of the band 1, thereby fixing its relative location on thestomach. It should be noted that stitches 6, as well as the stitches 12,may be replaced by any other suitable fastening means.

Reference is made to FIGS. 3 a and 3 b, illustrating a gastric band 14in its opened and closed positions, respectively. The band 14 hassomewhat different construction as compared to the band 1. To facilitateunderstanding, same reference numbers are used for identifying thosecomponents, which are identical in the bands 1 and 14. Here, at leastone so-called “bolt-and-nut” arrangement is provided serving as thefastening means. To this end, as shown in the figures in aself-explanatory manner, spaced-apart mushroom-like bolts, generally at16, project upwardly from the upper surface 2 a. Consequently, holes 18(four in the present example) are aligned along the longitudinal axis ofthe band in a spaced-apart parallel relationship. The diameter of thehole 18 corresponds to that of the head portion of the mushroom-likebolt 16 to put the bolt-and-nut arrangement into its engaged position,thereby closing the band.

In this specific example, the bolts 16 project from a plate-like support20, forming together an integral assembly, generally designated 22. Theassembly 22 is attached to the upper surface 2 a of the band 14 bystamping. The entire band, except for the assembly 22, may be made of apolymer material like Gortex, while the assembly 22 may be made of asubstantially rigid silicone. The bolts 16 (and consequently two locallyadjacent holes 18) are spaced from each other by the length L.sub.4 ofabout 7 mm, the dimensions of the plate 20 being as follows: the lengthL.sub.3=2 cm, and the width h.sub.3=12 mm. As shown in FIG. 3 b, afterclosing the band on the patient's stomach, two stitches 24 (or the like)are provided to ensure the fixed diameter of the band, and thereby ofthe stomach opening. Similarly to the previously described embodiments,the corresponding part of the end portion 1 b is cut off, while theopposite part 1 a protrudes from the band to be detectable.

FIGS. 4 a and 4 b illustrate a gastric band, generally at 26, accordingto yet another embodiment of the invention. Similarly, same referencenumbers are used for identifying those components, which are identicalin the bands 1, 14 and 26. The band 26, in distinction to the bands 1and 14, has its inner surface 2 b formed of a relatively flexiblematerial relative to that of the outer surface. For example, this may beimplemented by coating a center part of the inner surface of the band 26with silicone. As for the outer surface 2 a of the band 26, as well asthe inner surface thereof within the end portions, they are made of asubstantially non-extendable material. The end portion 1 a should bemade of such a non-extendable material which is not too rigid in ordernot to harm the stomach, e.g. Gortex.

FIGS. 5 a and 5 b illustrate yet another construction of a gastric band27 using the same reference numbers for identifying the common elementsin the bands 1, 14, 26 and 27. In the band 27, similar to the band 26,the center part of its inner surface is formed with a substantiallyflexible material, e.g. flexible silicone, while the end portions aremade of a non-extendable material. As for the fastening means, in theband 27 the end portion 1 b is formed with teeth-like edges 16′.Consequently, a through-going opening 4′ is shaped in a manner to definea slot 18′ allowing a forward movement of the portion 1 b through theopening 4′, but preventing its sliding back out of the opening 4′ in theoperating (closed) position of the band 27. To this end, the center partof the outer surface 2 a, as well as the end portion 1 b, are made of asubstantially rigid material, e.g. rigid silicone. As indicated above,the opposite end portion 1 a should be made of a substantially flexiblematerial.

Reference is now made to FIGS. 6 a and 6 b illustrating two steps of atypically performed calibration stage for determining the desireddiameter of the stomach opening and defining its location to mount agastric band there. To this end, a calibrating device, generallydesignated 28, is used. The construction and operation of such acalibration device are known per se, and therefore need not be describedin detail, except to note the following. The device 28 comprises anupper, balloon-like portion 28 a associated with a suitable pump, whichis not specifically shown, and a lower projection 28 bb having asubstantially circular cross-section of the desired diameter D.sub.0.

Upon inserting the device 28 inside the stomach 10 through a stomachinlet 29, the balloon-like portion 28 a is inflated up to the volumeV.sub.1 corresponding to the diameter D.sub.1 of the portion 28 a, so asto substantially engage the inner circumference of the stomach 10. Thismaximum diameter D.sub.1 of the portion 28 a is determined in accordancewith the inflating pressure.

Thereafter, the device is partially deflated to such a volume V.sub.2that corresponds to the diameter D.sub.2 of the portion 28 a, and pulledupwardly up to the inlet 29. Such a position of the device 28 having theknown diameter D.sub.2 of its balloon-like portion 28 a actually allowsfor locating the projection 28 b, thereby defining the location formounting the gastric band. The calibrating device 28 also comprises apipe 30 installed thereinside, serving for aspirating the stomachcontents and checking whether the mounting of the band caused any damageto the stomach itself, as will be described more specifically furtherbelow with reference to FIG. 7 f.

Referring to FIGS. 7 a to 7 f, there are illustrated the mainoperational steps for laproscopic mounting of the gastric band, forexample constructed as described above with reference to FIGS. 3 a and 3b, on the patient's stomach. As indicated above, the position of theprojection 28 b defines the exact location for mounting the band. Hence,it defines the convenient locations for cuttings 32 a and 32 b to bemade in the stomach connecting tissue 32 at opposite sides of thestomach 10. An articulated gripping device 34 is typically used formounting the gastric band on the stomach 10. FIG. 7 a illustrates thatthe articulated gripping device 34 is sequentially pushed through theopenings 32 b and 32 a, to clamp the cone shaped end portion 1 b of theband 14. Then, by pulling the device 34, the band is threaded throughthe openings 32 a and 32 b, thereby engaging the back-side of thestomach (FIG. 7 b).

This having been done, a pair of gripping devices 36 and 37 are used forsupporting the end portion 1 a of the band, while the device 34 passesthrough the opening 4 and proceeds towards the cone shaped portion 1 b(FIG. 7 c). As shown in FIGS. 7 d and 7 e, by manipulating the grippingdevices 36 and 37, the cone shaped end portion 1 b is threaded throughthe opening 4 and pulled to close the band in a manner described abovewith reference to FIGS. 3 a and 3 b. The closed operating position ofthe band is illustrated in FIG. 7 f.

After completing the mounting of the gastric band 14, a pair of stitches24 are provided and, optionally, depending on the desired diameter, theend portion 1 b is partly cut off. To check whether the entire operationdid not damage the stomach and did not completely block the stomachopening, the following procedure is carried out. After the totaldeflation of the balloon 28 a (through a suitable pump-valve assembly38) and pulling of the calibrating device 28 upwardly towards the upperpart of the paunch, a colored liquid is injected into the pipe 30through an upper opening 39 of the device 28. It will be readilyunderstood that the non-passage of this liquid into the stomach throughthe lower end of the pipe 30 indicates of the blockage of the stomachopening. Likewise, any dripping of the colored liquid out of the stomachwould indicate of the dangerous condition of stomach perforation, whichshould immediately be treated.

Those skilled in the art will readily appreciate that variousmodifications and changes can be applied to the invention ashereinbefore exemplified without departing from its scope defined in andby the appended claims. For example, the gastric band may have anyappropriate dimensions, providing it is capable of providing the desireddiameter of the stomach opening and its free end portion is detectableby a suitable imaging system.

1. A non-inflatable gastric band sized and shaped to be mounted on theoutside of a patient's stomach during a laparoscopic procedure,comprising: (a) an elongated non-inflatable band formed of non-rigidPTFE and flexible enough for us in a laparoscopic procedure; (b) athrough-going opening in said material of said band at a location spacedfrom a butt-end of the band to define an extended end portion of saidmaterial past said opening including a section of about 3 cm in lengthenabling gripping the band material, said extended end portion freelyextending from the band when the band is in a closed operating position;and (c) an opposite end portion of the band shaped so as to beinsertable into said through-going opening for adjusting a desired innerdiameter of the band in said closed operating position and for fasteningthe opposite end portion to the band upon establishing the desireddiameter, wherein said extended end portion and the opposite portion aresized for gripping the band while mounting it onto the outside of astomach and adjusting the diameter of the band to bring it into itsoperating closed position during a laparoscopic procedure, and whereinsaid extended end portion extends sufficiently so as to facilitatedetection of the band while in a laparoscopic operative position andmounted on the stomach and enables gripping the band at said extendedend portion for readjusting the diameter of the inner stomach openingafter the band is brought into its laparoscopic operating position,wherein said gastric band is formed of a single material.
 2. The gastricband according to claim 1, further including a fastener comprising atleast one projection located on the outer surface of the band, and atleast one through-going hole for receiving said at least one projection,when the band is in the operating position around the stomach.
 3. Thegastric band according to claim 1, wherein the two ends of the band arefastened together by two or more stitches when the band is in theoperating position around the stomach.
 4. The gastric band according toclaim 1, wherein an inner surface of said band engaging the stomach hassubstantially circular shape when in the operating position of the band.5. The gastric band according to claim 1, wherein said predeterminedlength of the end portion is such as to enable the detection of thegastric band by a laparoscopic inspection tool.
 6. A system forlaparoscopically attaching the gastric band of claim 1 around apatient's stomach so as to define a certain diameter of the stomachopening, the system comprising: a calibration device which is insertableinto the stomach at a predetermined depth and three articulated grippingdevices, wherein the calibration device comprises: an upper portionhaving variable volume, and a lower projection-like portion having adiameter substantially equal to said certain diameter of the stomachopening to be defined by the band, and further comprising a pipeproviding access to the interior of the stomach and stomach contents ifany, wherein the location of said projection-like portion when in theinserted position of the calibration device defines the location of theband with respect to the stomach.
 7. A system according to claim 6wherein the lower projection-like portion is a rigid tube of fixeddiameter.
 8. A system according to claim 6 wherein the pipe extendsthrough the lower projection-like portion for aspiration of the contentsof the stomach.
 9. A method for attaching the gastric band of claim 1around a circumference of a patient's stomach so as to define a desireddiameter of the stomach opening and a desired volume of the stomachabove the opening, the method comprising: performing a calibration witha calibration device having a balloon-like inflatable upper portion anda lower substantially rigid projection-like portion having a fixeddiameter substantially equal to said desired diameter of the stomachopening and to define a plane of location where the gastric band is tobe attached, thereby defining the volume of the stomach above theopening, the calibration comprising: inserting the calibration deviceinside the stomach though a stomach inlet, inflating the upperinflatable portion up to a volume corresponding to a certain maximaldiameter thereof so as to substantially engage the inner circumferenceof the stomach; partially deflating said portion to a volumecorresponding to the diameter of the upper portion; and pulling thecalibration device towards the stomach inlet to thereby locate the lowerportion and define the location for mounting the gastric band; andlaparoscopically attaching the gastric band around the circumference ofthe patient's stomach at said location.
 10. The method of claim 9wherein attaching the gastric band comprises: inserting a grippingdevice through cuttings made in the stomach connecting tissue onopposite sides of the back of the stomach in the plane of location ofthe gastric band; clamping the opposite end portion of the band; andpulling the gripping device to thereby thread the band through thecuttings to engage the back side of the stomach; supporting the endportion of the band while passing the gripping device though saidthough-going opening of the band towards said opposite end portion ofthe band; manipulating arms of the gripping device to thread saidopposite end portion of the band through the through-going opening andclose the band tight around the lower projection-like portion of thecalibration device inside the stomach; holding together the end portionsof the band by two arms of the gripping device and fastening theopposite end portion to the outer surface of the band; and cutting off afree part of the opposite end portion of the band.
 11. A method of usinga gastric band, comprising: encircling an uninflatable band having firstand second ends and a through-going opening in a material of the bandspaced from the first end of the band a predetermined distance to definean extended end portion of the material of the band of a predeterminedlength enabling gripping the band material, at a position intermediateupper and lower ends of a stomach with an inner surface of said band incontact with the stomach, whereby said extended end portion freelyprotrudes from the band sufficiently so as to facilitate detection ofthe band when the band is in a closed operating position; engaging bothends of said band simultaneously, using laparoscopic instruments;pulling the second end of the band via the through-going opening, usingsaid laparoscopic instruments, until an opposite end portion of the bandwhich has been pulled via the through-going opening corresponds to adesired inner diameter of the stomach opening and a desired volume ofthe stomach above the opening; and fastening the opposite end portion tofixate said desired diameter.
 12. The method of claim 11, furtherincluding cutting off a free part of the opposite end portion of theband.
 13. The method of claim 11, wherein encircling the gastric bandaround the stomach comprises: making cuttings in the stomach connectingtissue on opposite sides of the back of the stomach in a desiredlocation of the gastric band; threading the band through the cuttings toengage the back side of the stomach; and positioning the two ends of theband at the front of the stomach for insertion of the second end portionin the through-going opening.
 14. The method of claim 11, wherein thedistance of insertion is determined by pulling the second end of theband until the band is tight around a fixed-diameter portion of acalibration device inserted inside the stomach.
 15. The method of claim11, comprising detecting said extended end portion when it protrudesfrom said band after closing of said band, by its protrusion.
 16. Thegastric band of claim 1, wherein said gastric band is formed of a singlelayer of material.
 17. The gastric band of claim 1, wherein saidopposite end portion and said through-going opening are configured sothat said opposite end portion is prevent from retracting through saidopening once inserted through the opening.
 18. A method of treatment,comprising: inserting a laparoscopic instrument into a body, thelaparoscopic instrument including a non-inflatable band made from of anon-extendable and flexible material, the band comprising a first andsecond end; inserting the first end of the band through a through-goingopening near the second end of the band using a laparoscopic instrument,the opening at a location spaced from the second end of the banddefining an extended end portion of said material past said opening; andgripping the extended portion using a laparoscopic instrument; includinga section of about 3 cm in length enabling gripping the band material,said extended end portion freely extending from the band when the bandis in a closed operating position.
 19. A method according to claim 18,further comprising: detecting the extended portion by a laparoscopicinspection tool after the band is brought into its laparoscopicoperating position.